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Clinical Trials/NCT06175728
NCT06175728
Completed
Not Applicable

Feasibility, Usability, Acceptability and Efficacy of a Novel Leg Strengthening Device (S-Press) for Strengthening Leg Muscles and Improving Physical Impairment During Hospital Admission

Sheffield Hallam University1 site in 1 country9 target enrollmentApril 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Deconditioning
Sponsor
Sheffield Hallam University
Enrollment
9
Locations
1
Primary Endpoint
Feasbility of use of S-Press by patients
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The proposed study will examine the use and effectiveness of a novel strength training device - The S-Press within an NHS environment. The S-Press is a portable exercise device that can be used seated or lying down and specifically targets the knee extensors and flexors. The knee extensors are particularly important in the performance of activities of daily living such as rising from a chair, walking up and down stairs and walking.

Resistance training is the most effective strategy to help to reduce muscle wasting in response to ageing or chronic disuse; however as current in-patient settings likely fail to produce an overload stimulus to the muscle for hypertrophy and strength gains, there is a need to develop new interventions and equipment to help deliver this. The S-Press is designed by a Physiotherapist with the goal of increasing muscle strength and improving physical function in patients who may be confined to their bed or chair or unable to join in with standard physiotherapy treatments.

This mixed methods study will examine the efficacy of the S-Press to improve muscle size using B-Mode Ultrasound and physical function, using sit to stand x5 with use over 6 weeks, alongside the qualitative experience of the use of the S-Press through a one to one semi structured interview.

Registry
clinicaltrials.gov
Start Date
April 1, 2021
End Date
September 4, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tom Maden-Wilkinson

Associate Professor

Sheffield Hallam University

Eligibility Criteria

Inclusion Criteria

  • Any in-patient admitted onto the ward sites for therapy intervention, assessed as medically stable and physically able to participate by nursing staff and able to provide informed written consent for participation.

Exclusion Criteria

  • Any patient who is unable to give informed consent.
  • Significantly confused patients - may not understand or retain the information to perform the exercises so will be excluded from this study.
  • Patients with unstable or deteriorating medical conditions or are acutely unwell with an infection.
  • Patients unable to do leg press exercise
  • Patients who have had major surgery or myocardial infarction within the past 6 months.
  • Patients who have major surgery scheduled during the intervention period.
  • Patients currently undergoing treatment for cancer
  • Patients who currently have high blood pressure that is uncontrolled (Systolic \>200mmHg or Diastolic \> 110mmHg)
  • Patients with a physical disability that precludes safe and adequate testing.

Outcomes

Primary Outcomes

Feasbility of use of S-Press by patients

Time Frame: through study completion, an average of 2 weeks

30 minute Semi Structured Interview

Feasbility of use of S-Press by Healthcare Professionals

Time Frame: through study completion, an average of 2 weeks

30 minute Semi Structured Interview

Secondary Outcomes

  • Muscle thickness(through study completion, an average of 2 weeks)
  • Heart rate during use(through study completion, an average of 2 weeks)
  • 5x Sit to Stand time(through study completion, an average of 2 weeks)
  • Diastolic Blood Pressure during use(through study completion, an average of 2 weeks)
  • Systolic Blood Pressure during use(through study completion, an average of 2 weeks)

Study Sites (1)

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